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Rivaroxaban beats dalteparin in Select-D: Time for new SoC?

Elvira Manzano
16 Jan 2018

Cancer patients at risk for recurrent venous thromboembolism (VTE) are less likely to experience a recurrence with rivaroxaban compared with dalteparin, the Select-D trial has shown, ushering in a new standard of care (SoC) for cancer-related VTE.

Rivaroxaban is a highly selective, oral, direct factor Xa inhibitor while dalteparin is an injectable low molecular weight heparin (LMWH) approved in the UK for extended treatment and prevention of acute VTE recurrence. LMWH treatment for 6 months is considered a standard of care prior to the Select-D trial.

In the trial, VTE recurrence at 6 months was lower with rivaroxaban vs dalteparin (4 percent vs 11 percent). [ASH 2017, abstract 625]

VTE in cancer patients is an important and increasingly frequent clinical challenge, said study author Dr Annie Young from the Warwick Medical School, University of Warwick, Coventry, UK. Young and her team compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily for a total of 6 months) with dalteparin (200 IU/kg daily at month 1, followed by 150 IU/kg at months 2 through 6) in 406 cancer patients with VTE.  Median age was 67 years, 95 percent were Caucasians.

Patients included those with an early or locally advanced disease, metastatic disease, or haematologic malignancies. Fifty-three percent had incidental pulmonary embolism and 47 percent had symptomatic lower-extremity proximal DVT. Sixty-nine percent were receiving active treatment (chemotherapy or targeted therapy) at the time of VTE.

At 6 months, patients positive for residual vein thrombosis and pulmonary embolism were randomized to placebo or rivaroxaban for another 6 months. VTE recurrence was the primary outcome, major and nonmajor bleeds (overt bleeds resulting in unscheduled contact with a physician, or discontinuation or interruption of the study drug), survival, acceptability and health economics were the secondary outcomes.

Major bleeds were similar in both groups, but the rate of clinically relevant nonmajor bleeds occurred more frequently with rivaroxaban compared with dalteparin (13 percent vs 2 percent).

Overall survival at 6 months was also similar in both groups at 70 percent (95 percent confidence interval [CI], 63–76 percent) with dalteparin and 74 percent (95 percent CI, 68–80 percent) with rivaroxaban).

“Now we have another option,” Young said. “However, my take-home message for clinicians is to have a careful discussion with their patients, to assess the risk of bleeding as well as the risk of recurrence.”

Another study, the Hokusai VTE Cancer trial, which was also presented at ASH 2017 showed that edoxaban was noninferior to dalteparin in patients with cancer-associated VTE. Recurrent VTE or severe major bleeding rates were comparable between agents, but major bleeding was higher with edoxaban.

Experts said the results of both trials may pave the way for a new standard of care for cancer-associated VTE.

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Most Read Articles
Prof. Cheuk-Chun Szeto, Dr. Winston W. S. Fung, 25 Jan 2018
A 65-year-old lady with a background of type 2 diabetes, hyperlipidaemia and chronic immune thrombocytopenia presented to us with a 2-week history of generalized malaise and myalgia. Shortly after the onset of myalgia, she was noted to have reduced urine output and the urine was described as dark in colour. Her regular medications included prednisolone, danazol, simvastatin, metformin, and human insulin. Upon further questioning, the patient admitted that her compliance to simvastatin and danazol used to be poor. However, she recently started to take both medications regularly after repeated education.
26 Dec 2017
Supplementation with omega-3 fatty acids in combination with rosuvastatin may yield significant reductions in triglycerides and nonhigh-density lipoprotein (HDL) cholesterol as compared with rosuvastatin monotherapy, according to data from the ROMANTIC (rosuvastatin-omacor in residual hypertriglyceridemia) trial.
Jairia Dela Cruz, 26 Jun 2018
The monoclonal antibody denosumab is safe and effective for use in patients on glucocorticoids and at risk of developing fractures, with a recent study showing that the drug performs better than risedronate in increasing bone mineral density (BMD).
Pearl Toh, 20 Mar 2018
Not only does treatment with the PCSK9* inhibitor alirocumab reduces cardiovascular (CV) events along with plunges in LDL-C levels, it was also associated with a reduced risk of all-cause mortality compared with placebo in patient with a recent acute coronary syndrome (ACS) and persistently high cholesterol despite maximal statin therapy, according to top-line results from the ODYSSEY** Outcomes trial.